Thursday, September 10, 2015

News Watch: "Medical Testing is So Hot Right Now!"

Two articles within a few days on the theme that medical testing, venture investment, and direct to consumer topics are riding a wave.

From Wired.com, here, September 4, 2015, the article "Medical Testing is So Hot Right Now. This Startup Wants In." The journalist interviews the founders of CoFactor Genomics and writes,

Why don’t the two of you tell me how you plan to diagnose disease from little rings of RNA that most biologists considered junk three years ago? Let’s talk about your $1.5 million National Institutes of Health grant. While we’re at it, why did you decide to temporarily uproot your company—which is nearly a decade old and already pulling in millions of dollars—to join Y Combinator, the startup boot camp known more for putting nestling consumer tech companies like Instacart, Airbnb, and Dropbox into high orbit?

Biotechnology startup Pathway Genomics Corp. is introducing the first “liquid biopsy” tests designed to detect cancer-associated mutations in the blood of healthy people who are at high risk of developing tumors....Pathway, a closely held firm backed by investors including International Business Machines Corp. and venture capital firm Founders Fund, is offering its CancerIntercept Detect test for $699, according to Chief Executive Officer Jim Plante. The price tag drops to $299 if the consumer signs up to be tested once a quarter.
“The cost is a big advantage because a liquid biopsy could be one-10th or one-20th the cost of an invasive biopsy,” Plante said. “There’s a lot of value here for the patient and consumer.”

The FDA shared the market's skepticism, asserting that the test was improper for marketing. For trade press, here. For the FDA's September 21, 2015 letter, here. Pathway Genomics has received warning letters from the FDA in prior years (here, here).

The FDA seems polite enough in writing:

[We] believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health. We would like to discuss with you your offer of the CancerInterceptTM Detect and the associated blood specimen collection device, and any validation strategies you have undertaken beyond those reported in the publications cited in your white paper, including your determination of the test’s clinical sensitivity and specificity and the corresponding positive and negative predictive values for its claimed intended use. Given the importance of your claims, we request an acknowledgement of receipt of this letter and a proposed timeline for meeting with the FDA within 15 business days.

On September 24, 2015, Pathway Genomics issued a public blog posting commenting on the most recent FDA letter (here):

Pathway Genomics greatly respects and shares the FDA’s concerns about patient safety. We have received a letter from FDA, dated September 21, 2015, requesting certain information regarding the Pathway Genomics CancerIntercept™ Detect testing service. We are carefully considering the concerns of the FDA as stated in their letter, and we will be responding to that letter. We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept™ testing. We believe that CancerIntercept™ Detect is a laboratory developed test and, as a CLIA and CAP certified clinical laboratory, we are offering it as such. While Pathway Genomics is involved in educating and marketing the tests to physicians and consumers, we do not believe this is a direct-to-consumer model. We believe we have performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies.

About the Author

Bruce Quinn MD PhD is an expert on health reform, innovation, and Medicare policy. He helps both large and small companies understand and overcome hurdles to commercialization, as well as craft business strategies for a changing environment. CONTACT Dr. Quinn through www.brucequinn.com. BACKGROUND: Dr. Quinn has worked in academic medicine, Accenture business strategies, and for the Medicare program. EDUCATION: Stanford MD/PhD, MIT Postdoc, Kellogg MBA.